A Study to Look at Performance of MICRUSFRAME and GALAXY Coils for the Treatment of Intracranial Aneurysms (STERLING)

A Prospective, Multi-center, Single Arm Study to Obtain "Real World" Clinical Data and Characterize the Acute and Long-term Performance of the MICRUSFRAME and GALAXY Coils Including the PulseRider Aneurysm Neck Reconstruction Device for the Endovascular Treatment of Intracranial Aneurysms

A post-market registry evaluating ruptured/unruptured aneurysms treated with MICRUSFRAME and GALAXY coils

Study Overview

• Status: Completed
• Conditions: Aneurysms
• Intervention / Treatment: Device: MICRUSFRAME and GALAXY coils

Detailed Description

A registry to collect real world data on the use of Cerenovus coils. The study will be a post-market registry evaluating ruptured/unruptured aneurysms treated with MICRUSFRAME and GALAXY coils

• Study Type: Interventional
• Enrollment (Actual): 723
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Kortrijk, Belgium
    • Algemeen Ziekenhuis Groeninge
• France
  • Amiens, France
    • Centre Hospitalier Universitaire d'Amiens Picardie
  • Bordeaux, France
    • Centre Hospitalier Universitaire de Bordeaux
  • Lille, France
    • Hopital Roger Salengro-Centre Hospitalier Universitaire de Lille
  • Nancy, France
    • Praticien Hospitalier Université de Lorraine
  • Tours, France
    • Centre Hospitalier Régional Universitaire de Tours
• Germany
  • Lübeck, Germany
    • Universitatsklinikum Schleswig Holstein
• Israel
  • Nahariya, Israel
    • Galilee Hospital Naharyia
• Italy
  • Milan, Italy
    • Ospedale Niguarda Ca' Granda
  • Roma, Italy
    • Policlinico Tor Vergata
  • Sicily, Italy
    • Ospedale Cannizzaro
• Japan
  • Aichi, Japan
    • Aichi Medical University Hospital
  • Okayama, Japan
    • Okayama University Hospital
  • Osaka, Japan
    • National Hospital Organization Osaka National Hospital
  • Osaka, Japan
    • Tominaga Hospital
  • Sendai, Japan
    • Kohnan Hospital
  • Yokohama, Japan
    • Meihokai Yokohama Shin-Toshi Brain Orthopedic Hospital
• Portugal
  • Porto, Portugal
    • Centro Hospitalar de Vila Nova de Gaia
• Spain
  • Valencia, Spain
    • Hospital Universitari i Politecnic La Fe
• Switzerland
  • Geneva, Switzerland
    • Hôpitaux universitaires de Genève
  • Zurich, Switzerland
    • University Hospital Zurich
• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona
  • California
    • Carmichael, California, United States, 95608
      • Mercy San Juan Medical Center
    • Orange, California, United States, 92868
      • University of California Irvine
  • Florida
    • Gainesville, Florida, United States, 32608
      • University of Florida
    • Jacksonville, Florida, United States, 32207
      • Baptist Medical Center
    • Miami, Florida, United States, 33136
      • University of Miami
  • Georgia
    • Savannah, Georgia, United States, 31405
      • Memorial Health University
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University
    • Rockford, Illinois, United States, 61103
      • Javon Bea Hospital
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Norton Healthcare
  • Maine
    • Scarborough, Maine, United States, 04074
      • Maine Medical Center
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts
  • Missouri
    • St Louis, Missouri, United States, 63110
      • St. Louis University
  • New York
    • Buffalo, New York, United States, 14075
      • University of Buffalo
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
    • Stony Brook, New York, United States, 11794
      • Stony Brook University
    • Valhalla, New York, United States, 10595
      • Westchester Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Toledo, Ohio, United States, 43604
      • Mercy Health St. Vincent Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Clinic
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Greenville, South Carolina, United States, 61103
      • Greenville Health System
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Tennessee Interventional and Imaging Associates
    • Knoxville, Tennessee, United States, 37920
      • University Of Tennessee
  • Texas
    • Plano, Texas, United States, 75075
      • Texas Stroke Institute
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patient is between 21 and 80 years of age
2. Patient has an intracranial saccular aneurysm, ruptured or unruptured, suitable for embolization with coils
3. Patient is able and willing to comply with protocol and follow-up requirements

Exclusion Criteria:

1. Pre-planned staged procedure on unruptured aneurysm
2. More than one aneurysm requiring treatment during the course of study
3. Fusiform aneurysm

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Coils; MICRUSFRAME and GALAXY coils	Device: MICRUSFRAME and GALAXY coils; MICRUSFRAME and GALAXY Coils

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Achieved Adequate Occlusion (Modified Raymond-Roy I or II Classification) as Assessed by the Independent Core Lab Report of the Target Aneurysm at 1 Year Without Retreatment	Number of participants who achieved adequate occlusion as assessed by the independent core lab report of the target aneurysm at 1 year without retreatment was reported. Adequate occlusion was defined as the achievement of a Modified Raymond-Roy classification of the aneurysm at 1 year without retreatment. Modified Raymond-Roy Classification scale is a system used to grade the angiographic results of endovascular treatment of brain aneurysms. Class I represents complete obliteration of the aneurysm. Class II indicates residual neck, defined as persistence of a portion of the original arterial wall defect without opacification of the aneurysmal wall. Class III is subdivided into IIIa and IIIb: Class IIIa refers to residual aneurysm filling with contrast opacification within the coil interstices, whereas Class IIIb denotes residual aneurysm filling with contrast outlining the aneurysm wall.	At 1 year Post Procedure on Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Packing Density Percentage (%) as Assessed by Independent Core Lab	Packing density was defined as the ratio of the volume of coils to the volume of the coiled part of the aneurysm achieved during the procedure. Packing density is expressed as percentage.	During procedure (Day 1)
Number of Participants With Complete Occlusion at 1 Year as Assessed by the Independent Core Lab (Modified Raymond-Roy I Classification)	Number of participants with complete occlusion at 1 year was reported as assessed by the independent core lab was reported. Complete occlusion was defined as achieving Modified Raymond-Roy I classification at 1 year, as assessed by the independent core lab. Modified Raymond-Roy I or II Classification scale is a system used to grade the angiographic results of endovascular treatment of brain aneurysms. Class I represents complete obliteration of the aneurysm. Class II indicates residual neck, defined as persistence of a portion of the original arterial wall defect without opacification of the aneurysmal wall. Class III is subdivided into IIIa and IIIb: Class IIIa refers to residual aneurysm filling with contrast opacification within the coil interstices, whereas Class IIIb denotes residual aneurysm filling with contrast outlining the aneurysm wall.	At 1 year Post Procedure on Day 1
Recanalization Rate at 1 Year as Assessed by Independent Core Lab	Recanalization rate is defined as number of participants with recanalization. Recanalization was defined as a worsening in aneurysm occlusion grading using the Modified Raymond-Roy Classification (MRRC) scale. MRRC scale is a system used to grade the angiographic results of endovascular treatment of brain aneurysms. Class I represents complete obliteration of the aneurysm. Class II indicates residual neck, defined as persistence of a portion of the original arterial wall defect without opacification of the aneurysmal wall. Class III is subdivided into IIIa and IIIb: Class IIIa refers to residual aneurysm filling with contrast opacification within the coil interstices, whereas Class IIIb denotes residual aneurysm filling with contrast outlining the aneurysm wall.	At 1 year Post Procedure on Day 1
Number of Participants With Modified Rankin Score (mRS) 0-2 With Unruptured Aneurysms	Number of participants with mRS 0-2 with unruptured aneurysm was reported. The Modified Rankin Scale (mRS) is a 7 point measure of functional outcome ranging from 0 to 6, where higher scores indicate greater disability. A score of 0 reflects no symptoms, 1 denotes no significant disability despite minor symptoms, 2 indicates slight disability with independence in personal affairs, 3 corresponds to moderate disability requiring some help but able to walk unassisted, 4 represents moderately severe disability with dependence for bodily needs and inability to walk alone, 5 signifies severe disability requiring constant care, and 6 indicates death. Increasing scores indicate worsening outcomes.	From baseline (Day 1 of procedure) to 1 year post procedure on Day 1
Number of Participants With Retreatment (Surgical or Endovascular)	Number of participants with any retreatment (surgical or endovascular) was reported. Retreatment is defined as any type of additional treatment (surgical or endovascular) of the target aneurysm after the index procedure.	From baseline (Day 1 of procedure) to 1 year post procedure on Day 1
Number of Participants With Device Related Serious Adverse Events (SAEs)	An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. A serious adverse event (SAE) is defined as an adverse event that led to death, led to serious deterioration in the health of the participant, users, other persons as defined by one or more of the following: a life-threatening illness or injury, or a permanent impairment of a body structure or a body function including chronic diseases, or in-patient or prolonged hospitalization, or medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function led to fetal distress, fetal death or a congenital abnormality or birth defect including physical or mental impairment.	From Day of procedure (Day 1) up to 1 year

Collaborators and Investigators

• Sponsor: Cerenovus, Part of DePuy Synthes Products, Inc.
• Investigators: Principal Investigator: Reade De Leacy, Mount Sinai Hospital, New York; Principal Investigator: Osama Zaidat, Mercy Health St. Vincent Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2018
• Primary Completion (Actual): June 12, 2025
• Study Completion (Actual): June 12, 2025

Study Registration Dates

• First Submitted: July 11, 2018
• First Submitted That Met QC Criteria: August 21, 2018
• First Posted (Actual): August 22, 2018

Study Record Updates

• Last Update Posted (Actual): July 9, 2026
• Last Update Submitted That Met QC Criteria: June 12, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aneurysm
• Other Study ID Numbers: CNV_2017_01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes